Deborah Bartz, Planned Parenthood League of Massachusetts, 2008
See also executive summary.

Project abstract

Background and significance: Globally there is a dearth of access to safe second trimester abortions. Preoperative cervical ripening improves the safety of these procedures. Prior clinical and pharmacokinetic studies suggest vaginal misoprostol and Dilapan-S™ are effective for faster cervical ripening, allowing early second trimester abortions to be performed in a single day. However, it is unknown which agent is best.

Objectives: To compare the efficacy and acceptability of same day misoprostol and Dilapan-S™ for cervical ripening before early second trimester surgical abortion in nulliparous and multiparous women.

Study design and measurements: In this randomized, double-blinded controlled trial patients will receive misoprostol 400 micrograms vaginally or one to two 4 millimeter Dilapan-S™ rod(s) three to four hours before dilation and evacuation at 12 0/7 to 15 0/7 weeks gestation. The primary outcome measured will be level of preoperative dilation. A sample size of 32 nulliparous and 32 multiparous subjects in each treatment arm is based on 90% power and alpha of 0.05. Secondary outcomes include ease of further mechanical dilation, procedure time, complication rates, and patient pain and satisfaction. For the primary analysis, we will compare initial cervical dilation between the two treatment groups and stratify by parity using a two-way ANOVA.

Study implication: Same-day cervical ripening agents can expand access to second trimester abortion. Many abortion providers already perform same-day second trimester procedures with limited evidence to guide their practice. This study will provide evidence of the most effective way to provide same-day second trimester abortion care. As the ideal method of performing same day second trimester services becomes clear, more providers may be willing to offer this service.